To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
Phase 3
Completed
- Conditions
- Primary Hypercholesterolemia
- Interventions
- Drug: Livalo, Ezetrol
- Registration Number
- NCT04584736
- Lead Sponsor
- JW Pharmaceutical
- Brief Summary
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.
- Detailed Description
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
Inclusion Criteria
- Patients with primary hypercholesterolemia
Exclusion Criteria
- The subject not meet the specified LDL-C level
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Livalo 2mg, Ezetrol 10mg Livalo, Ezetrol Pitavastatin 2mg, Ezetimibe 10mg Livalo 2mg Livalo, Ezetrol Pitavastatin 2mg Livalo 4mg, Ezetrol 10mg Livalo, Ezetrol Pitavastatin 4mg, Ezetimibe 10mg Livalo 4mg Livalo, Ezetrol Pitavastatin 4mg
- Primary Outcome Measures
Name Time Method % change in LDL-C level from baseline at Week 8 Week 8 change in LDL-C level
- Secondary Outcome Measures
Name Time Method Change in LDL-C level from baseline at Week 4 and Week 8 Week 4 and Week 8 change in LDL-C level
Trial Locations
- Locations (1)
Gangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Korea, Republic of